Tracheal tubes are inserted into the airway of patients in medical situations where the patient is unable to breathe on his own due to obstructions or lack of awareness/consciousness on the patient's part. Tracheal tubes aid in mechanically ventilating patients until the patients are able to breathe on their own. Most tracheal tubes currently in use include an inflatable cuff or balloon between the tracheal tube and the walls of the patient's trachea. The balloon or cuff blocks off the airway passage and establishes a closed system where gas pressure to the patient's lungs can be more easily regulated and the cuff or balloon helps to prevent passage of fluids and debris into the patient's trachea. FIGS. 1A-1B show typical respiratory tract locations where fluid might build in an intubated patient. While FIG. 1A shows that primary fluid accumulation typically occurs above an inflatable cuff of a tracheal tube, FIG. 1B shows that other regions along the trachea of an intubated patient may also be susceptible to fluid accumulation.
A major complication associated with intubation and the use of tracheal tubes is ventilator-associated pneumonia (VAP). VAP is a type of lung infection that occurs in patients who are placed on ventilators. VAP typically affects those who are already weak, such as patients in an intensive care unit (ICU) and/or with compromised immune systems. Developing VAP can increase the length of time a patient is in the ICU and the hospital. VAP also increases the likelihood of death by 20-30%.
VAP generally occurs because the tracheal tube allows passage of bacteria into the lower portions of the lung in an intubated patient. These patients may already have underlying issues that decrease their resistance to bacteria. Bacteria may thrive in the fluid accumulated around the tracheal tube, especially where there are bends in the tracheal tube which allow fluid to accumulate. Thus the initial bend in the tracheal tube between the back of the oral cavity and just past the pharynx, as well as the area above the inflatable cuff or balloon, may be especially prone to fluid and mucous accumulation. When patients remain on a ventilator for extended periods, the risk of bacterial infection increases. Further, bacteria also may be drawn down towards the lung when breathing. In addition, the bacteria that cause VAP can be differentiated from bacteria that cause the more common community-acquired pneumonia (CAP). Several bacteria associated with VAP are resistant to commonly-used antibiotics. Thus it would be desirable to minimize the amount of fluid collecting along the tracheal tube that can provide a hospitable media for bacteria to grow.
Existing mechanism for addressing the fluid build-up around a tracheal tube are not adequate. In the majority of currently available and described systems, the apparatus is only designed to draw fluid away from the tracheal tube at one location or if there is potential for more than one location of suction along the tracheal tube, the additional area is limited to the region immediately above the inflated cuff or balloon. In some variations ports are disposed along a tracheal tube at two locations, but these locations are not associated with specific anatomical locations on a patient. For example, U.S. Pat. No. 8,434,488 ('488) describes a tracheal tube with multiple ports that are integrated with the main tracheal tube opening. The tracheal tube in '488 includes only one suction lumen where the suctioning occurs in slightly distal to the cuff. The '488 tracheal tube also includes a line for inflating the cuff and maintaining a certain pressure within the cuff. FIGS. 1C and D shows traditional fluid management systems where suction only occurs at the region directly above the inflatable cuff. In addition, traditional fluid management systems require the caregiver to manually suction out any fluid present throughout the course of time that a patient is intubated, which requires more staff time of an already short-staffed health system.
Thus, there exists a need for fluid management apparatuses for use with ventilation that can monitor for fluid accumulation along different regions of a respiratory (e.g., tracheal) insert and automatically and periodically remove fluid.